Cytokinetics Inc CYTK:NASDAQ

Last Price$50.30NASDAQ Previous Close - Last Trade as of 4:00PM ET 8/12/22
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Cytokinetics Says Prescription Drug User Fee Act Date for Heart Failure Treatment Application Extended by Three Months

9:29AM ET 6/17/2022 MT Newswires
Cytokinetics (CYTK) said Friday the US Food and Drug Administration has extended the Prescription Drug User Fee Act date for the company's new drug application for omecamtiv mecarbil by three months to Feb. 28, 2023.

The extension will give the FDA more time to review the submission, which was recently supplemented by additional pharmacokinetic analyses in response to a request from the regulator, the late-stage biopharmaceutical company said.

The additional data constitutes a major amendment to the new drug application for omecamtiv mecarbil, an investigational treatment for patients suffering from worsening heart failure.

The company's shares were nearly 2% lower in recent activity.

Price: 39.05, Change: -0.6, Percent Change: -1.51